- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03563950
An Investigational Study to Evaluate the Effect of Rifampin on the Singe Dose of Experimental Medication BMS-986224 in Healthy Participants
August 28, 2018 updated by: Bristol-Myers Squibb
A Phase I, Open-Label Study to Evaluate the Effect of Rifampin on the Single Dose Pharmacokinetics, Safety and Tolerability of BMS-986224 in Healthy Subjects
The purpose of this study is to investigate if the blood levels of experimental medication BMS-986224 will be changed when given together with Rifampin, an antibiotic that affects specific enzymes involved with the breakdown of BMS-986224.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Utah
-
Salt Lake City, Utah, United States, 84107
- PRA Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
Inclusion Criteria:
- Healthy participant, as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
- Body mass index (BMI)of 18.0to 30.0 kg/m2, inclusive, at screening
Exclusion Criteria:
- Women of childbearing potential
- Any significant acute or chronic medical illness
- Current or recent (within 3 months of study treatment administration) gastrointestinal disease that could affect absorption or history of cholecystectomy
Other protocol defined inclusion/exclusion criteria may apply
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Rifampin + BMS-986224
Oral administration
|
Specified dose on specified days
Specified dose on specified days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Maximum observed plasma concentration (Cmax) of BMS-986224
Time Frame: 5 days
|
5 days
|
Area under the plasma concentration-time curve from time zero to time of last quantifiable concentration [AUC(0-T)] of BMS-986224
Time Frame: 5 days
|
5 days
|
Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)] of BMS-986224
Time Frame: 5 days
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Biomarker plasma concentrations of BMS-986224
Time Frame: 5 days
|
5 days
|
Time of maximum observed plasma concentration (Tmax) of BMS-986224
Time Frame: 5 days
|
5 days
|
Terminal elimination half-life (T-HALF) of BMS-986224
Time Frame: 5 days
|
5 days
|
Metabolite of BMS-986224 Cmax
Time Frame: 5 days
|
5 days
|
Metabolite of BMS-986224 AUC(0-T)
Time Frame: 5 days
|
5 days
|
Metabolite of BMS-986224 AUC(INF)
Time Frame: 5 days
|
5 days
|
Incidence of nonserious adverse events (AE)
Time Frame: 17 days
|
17 days
|
Incidence of serious adverse events (SAE)
Time Frame: 30 days
|
30 days
|
Incidence of AEs leading to discontinuation
Time Frame: 17 days
|
17 days
|
Composite results of vital signs, electrocardiograms, physical examinations,and clinical laboratory tests
Time Frame: 18 days
|
18 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2018
Primary Completion (Actual)
July 27, 2018
Study Completion (Actual)
July 27, 2018
Study Registration Dates
First Submitted
June 11, 2018
First Submitted That Met QC Criteria
June 11, 2018
First Posted (Actual)
June 20, 2018
Study Record Updates
Last Update Posted (Actual)
August 29, 2018
Last Update Submitted That Met QC Criteria
August 28, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Anti-Bacterial Agents
- Leprostatic Agents
- Cytochrome P-450 Enzyme Inducers
- Cytochrome P-450 CYP3A Inducers
- Antitubercular Agents
- Antibiotics, Antitubercular
- Cytochrome P-450 CYP2B6 Inducers
- Cytochrome P-450 CYP2C8 Inducers
- Cytochrome P-450 CYP2C19 Inducers
- Cytochrome P-450 CYP2C9 Inducers
- Rifampin
Other Study ID Numbers
- CV016-008
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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